I. The Minister of Health and FAMHP can take special individual and/or collective measures to address drug shortages in the framework of the COVID-19 pandemic.
II. The FAMHP, the Clinical Trial College and the Belgian Association of Research Ethics Committees (BAREC) have issued a Belgian Guidance on the Management of Clinical Trials during the COVID-19 pandemic.
III. Two special taskforces have been set up: a taskforce responsible for the hospital capacity and a taskforce responsible for the scarcity of protective equipment and medical devices.
IV. Product allocation systems do not need revisiting at this stage but developments should be closely monitored
I. Drug shortages
Since 25 March, the Minister of Health and the Federal Agency for Medicines and Health Products (FAMHP) can take special individual and/or collective measures to address drug shortages in the framework of the COVID-19 pandemic (Royal Decree of 24 March 2020 on special measures to address shortages of medicines in the framework of the SARS-CoV-2 pandemic). They have the competence to:
- restrict or prohibit the export of any medicinal product or starting material;
- limit the supply of a medicine to a maximum quantity per patient;
- limit the supply of a medicine or raw material to pharmacies to a fixed quantity per pharmacy; reserve the supply of a medicine for hospital dispensaries;
- order the redistribution of stocks of a medicinal product or a starting material, either by way of a return to the wholesaler or by way of direct redistribution among pharmacies;
- commandeer stocks of a medicinal product or a starting material to redistribute it;
- authorise and regulate the delivery of medicines by doctors or other healthcare professionals;
- order that the stock of medicines at wholesalers can only be sold or delivered according to the instructions of the FAMHP.
They can only take such measures if they can demonstrate their necessity, proportionality and adequateness. Moreover, the measure taken must be limited in time. The Belgian State is obliged to compensate the damage resulting from the measures taken.
Currently, the FAMHP has already taken the following measures:
- All stocks of Plaquenil, chloroquini phosphas and Kaletra from wholesalers, wholesaler distributors and pharmaceutical companies are quarantined;
- Pharmacies open to the public are only supplied with the amount of Plaquenil, chloroquini phosphas and Kaletra necessary to meet medical prescriptions for chronic patients;
- General practitioners have been recommended to restrict the prescription of Plaquenil, chloroquini phosphas and Kaletra.
- Pharmacies (physical and online) are requested not to supply more than one box per patient of medicines/preparations containing only paracetamol, unless a medical prescription states otherwise.
- The sale of rapid diagnostic tests used for the measurement or detection of SARS-CoV-2 related antibodies, such as IgG, IgM and IgA, has been banned for six months as from 18 March 2020.
II. Clinical trials
The FAMHP, the Clinical Trial College and the Belgian Association of Research Ethics Committees (BAREC) have issued a Belgian Guidance on the Management of Clinical Trials during the COVID-19 pandemic. This document must be read in conjunction with the European Guidance on Clinical Trials issued on 20 March. The Belgian guidance will be regularly updated in line with the evolution of the pandemic.
The Guideline indicates that priority will be given to any (new) clinical trial application related to the treatment or prevention of COVID-19 infections. For multi-country COVID-19 related trials, the guidance draws attention to the accelerated Voluntary Harmonisation Procedure. For national COVID-19 related trials, it strongly recommends the accelerated CTR Pilot because a single review by the selected evaluating EC (without possible local EC's) is sufficient.
The accessibility of healthcare facilities can be restricted due to COVID-19 measures. When the participating patient cannot go to the investigator site, home nursing and/or contact via phone may be required. Direct shipment of trial medication from sponsor to patient is still not allowed in Belgium, but the medication can be directly shipped to the trial participant under the responsibility of the principal investigator. Only trial medication which is suitable for transport, storage at home and administration at home use is eligible for direct shipment. Moreover, special training must be provided to the participant, caregiver, nurse or physician on the home administration of the trial medication. Several investigators have cancelled on-site monitoring at their study site. The guidance does not recommend remote source data verification by the sponsor (e.g. providing sponsor with copies of medical records or remote access to electronic medical records) as an alternative solution considering that direct access to medical records violates the participants' rights. Instead, special attention needs to be paid to onsite monitoring once restored.
Two special taskforces have been set up by the Belgian government. The first taskforce is responsible for the hospital capacity in Belgium. The second taskforce aims to find immediate solutions for the scarcity of protective equipment and medical devices on the Belgian market.
IV. Impact on product allocation systems
Pharmaceutical companies that apply a product allocation system, may see such system impacted by one or more of the measures described above. In particular, by measures dealing with drug shortages such as limiting supplies to patients or pharmacies, or ordering the redistribution of stock. Similarly, wholesalers and hospitals may be inclined to build up stock, which could also affect demand for products. Whilst product allocations may be impacted in light of the specific circumstances, at this stage there does not appear to be a reason for pharmaceutical companies to revisit their product allocation systems. However, companies operating such systems should closely monitor developments and take care about their communications externally and internally in relation to their product allocation.